CN1857343A - Chinese medicine composition for preventing and treating viral cold and throat disease and its preparing method - Google Patents
Chinese medicine composition for preventing and treating viral cold and throat disease and its preparing method Download PDFInfo
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- CN1857343A CN1857343A CN 200610200334 CN200610200334A CN1857343A CN 1857343 A CN1857343 A CN 1857343A CN 200610200334 CN200610200334 CN 200610200334 CN 200610200334 A CN200610200334 A CN 200610200334A CN 1857343 A CN1857343 A CN 1857343A
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Abstract
The present invention relates to a kind of Chinese medicine composition for preventing and treating viral cold and throat diseases and its preparation process. The Chinese medicine composition is prepared with acute turpinia leaf and one or several algefacients, including mint oil, menthol, borneol and eucalyptus oil as well as pharmaceutically acceptable carrier or excipient. It has excellent antibiotic, antiphlogistic and analgetic functions, and possesses obvious effect of preventing and treating viral cold and throat diseases.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition, particularly be used to prevent and treat the Chinese medicine composition of viral influenza and laryngopharyngeal diseases, relate to preparation method, purposes and the method for quality control of said composition simultaneously.
Background technology
Viral influenza and laryngopharyngeal diseases are a kind of very diseases of seeing more, and most people will suffer from first and second every year at least, and wherein child's sickness rate is the highest.According to another statistics, suffer from various degree laryngopharyngeal diseases people account among the crowd more than 40%.
In healthy population, various bad life style, as have a liking for tobacco and wine, often be in fatigue state, depression, work living environment is not good, the shortage solar radiation, or contact has the people of excitor substance, and do not get enough athletic exercise at ordinary times, the people to pessimal stimulation adaptive capacity differences such as hot and cold, moist, dryings becomes vulnerable crowd.Other with the excessive crowd of throat, show that according to relevant survey data in disease that the teacher takes a disease, stomatitis, pharyngolaryngitis have accounted for ratio over half as occupational factor, become the subject matter of puzzlement teachers ' health.And worldwide, air pollution, environmental problem become increasingly conspicuous, and this class disease that causes owing to the unfavorable reason of environmental pollution improvement also rises year by year.The frequent influenza that takes place, SARS, bird flu epidemic situation etc., these all propose new requirement to preventing and treating viral influenza and laryngopharyngeal diseases medicine.
Throat disease is a kind of multiple commonly encountered diseases, is difficult to thorough radical cure at present more, still the significant especially specific drug of inefficacy.The many interim disease controlling of western medicine, but frequently take too many anti-inflammatory agent, can cause human body self immunomodulating disequilibrium as antibiotic or sulfonamides, analgesic etc., cause immunologic hypofunction, resistance goes down, and causes the state of an illness difficult repeatedly.Chinese medicine is showing huge advantage because its toxic and side effects is little aspect these class diseases prevention and treatment, especially to the patient of child and old people and immunologic hypofunction, aspect the medication of needs longer-term and chronic disease prevent and treat, demonstrates bigger vitality; The major product in throat disease market has at present: JINSANGZIHOUBAO, Waterelon Frost Lozenges, FUFANG CAOSHANHU HANPIAN, cydiodine, Lotrimin Sol Lotrimin, JIANMIN YINHOU PIAN etc.Other are as some are to remove halitosis, to make oral cavity, throat produce refrigerant sense on the market, and the larynx moistening candy of refreshment health-care effect then belongs to leisure.
So seek viral influenza and laryngopharyngeal diseases are had the Chinese medicine of better preventive and therapeutic effect, and be applied to market, have great importance.
Summary of the invention
Turpinia pomifera(Roxb) D O. (Turpinia arguta seem) is a Staphyleaceae Turpinia pomifera(Roxb) D O. platymiscium, and its leaf has effects such as anti-inflammation, analgesia, and main active is chemical constituents such as flavonoid, organic acid, glycoside; State Food and Drug Administration's drug data bank by retrieval, Turpinia pomifera(Roxb) D O. patent medicine preparation has Turpinia pomifera(Roxb) D O. granule, Caulis et Folium Hyptidis suaveolentis disk, Turpinia pomifera(Roxb) D O. buccal tablet etc., the clinical exuberant lung-stomach heat that all is used for, pharyngitis, acute tonsillitis at present, the treatment of laryngopharynx swelling and pain, the Turpinia pomifera(Roxb) D O. pharmaceutical composition does not appear in the newspapers at present.
The invention reside in provides a kind of Chinese medicine composition, particularly is used to prevent and treat the Chinese medicine Turpinia pomifera(Roxb) D O. compositions of viral influenza and laryngopharyngeal diseases, relates to preparation method, purposes and the method for quality control of said composition simultaneously.
The initial purpose of Chinese medicine composition of the present invention is to add a kind of freshener in the Chinese medicine Turpinia pomifera(Roxb) D O. and aromatic is taken mouthfeel with improvement, such as Oleum menthae, Mentholum, Borneolum Syntheticum, Oleum Eucalypti, apple essence, Fructus Citri Limoniae essence, Fructus Citri tangerinae essence etc.Yet find to be added with its antibacterial effect of compositions of some fresheners (as Oleum menthae, Mentholum, Borneolum Syntheticum, Oleum Eucalypti) and the laryngopharyngeal diseases action effect is improved, taking dose reduces, i.e. this combination is not the simple addition of Turpinia pomifera(Roxb) D O. and freshener, but having played synergistic function mutually, the Chinese medicine composition of being invented also has significant preventive and therapeutic effect to viral influenza.
The present invention can realize by following technical method.
A kind of Chinese medicine composition of preventing and treating viral influenza and laryngopharyngeal diseases is characterized in that this Chinese medicine composition mainly is made up of Turpinia pomifera(Roxb) D O. and freshener, and freshener is one or more in Oleum menthae, Mentholum, Borneolum Syntheticum, the Oleum Eucalypti.Leaf of Turpinia pomifera (Roxb) D O. is pressed dry product and is calculated, and with the freshener weight proportion is: 1000～5000: 0.2～30, and the preferred weight proportioning is a leaf of Turpinia pomifera (Roxb) D O.: freshener (1000～2000: 0.5～5).Said composition is that leaf of Turpinia pomifera (Roxb) D O. or its extract and freshener and pharmaceutically acceptable excipient are made various pharmaceutical preparatioies or the health food service form that is suitable for clinical practice.
Described leaf of Turpinia pomifera (Roxb) D O. or its extract comprise any mixture of the bright product of leaf of Turpinia pomifera (Roxb) D O. dry product and leaf of Turpinia pomifera (Roxb) D O. or leaf of Turpinia pomifera (Roxb) D O. dry product and leaf of Turpinia pomifera (Roxb) D O. aquatic foods product, and the leaf of Turpinia pomifera (Roxb) D O. extract that obtains behind preparation technology of leaf of Turpinia pomifera (Roxb) D O. and their any mixture thereof.
Described freshener is one or more any mixture in Oleum menthae, Mentholum, Borneolum Syntheticum, the Oleum Eucalypti.The mouthfeel of the undue stimulation that may bring when covering the freshener large usage quantity also increases freshener stability and discharges continuously, and described freshener can be with the form of ready-made clathrate, solid absorption or solid dispersion.
This prevents and treats the Chinese medicine composition of viral influenza and laryngopharyngeal diseases, can also contain one or more combination in any of Chinese medicine with relieving sore-throat by clearing away heat, antipyretic and antidote functions and extract thereof in the compositions.Include but are not limited to: watermelon crystal; Herba Sarcandrae; Flos Lonicerae; Radix Scutellariae; Fructus Canarii; Fructus Momordicae; Semen Sterculiae Lychnophorae; FRUCTUS TERMINALIAE IMMATURUS; Radix Glycyrrhizae; Radix Isatidis; Folium Isatidis; the artificial Calculus Bovis; Margarita powder; Flos Farfarae; Radix Rehmanniae; Fructus Mume; Flos Chrysanthemi; Flos Chrysanthemi Indici; Flos Trollii; Radix Scrophulariae; Radix Platycodonis; Fructus Gardeniae; Radix Ophiopogonis; Fructus Forsythiae; Radix Sophorae Tonkinensis; Radix Wikstroemae; fresh Succus Bambusae; Chimonanthus Nitens; Herba Houttuyniae; Herba Polygalae Japonicae; the Fructus Chebulae; Ilex purpurea Hassk.[I.chinensis Sims; Herba Lophatheri; Folium Mori; Semen Armeniacae Amarum; Semen Oroxyli; Radix Tinosporae; Herba Menthae; in the Radix Picriae felterrae etc. one or more and combination in any.
For adapting to the needs of mouthfeel, preparation outward appearance, can add correctives, coloring agent etc. in the composite preparation, to reach happier mouthfeel and diseases caused by exogenous pathogenic factor.Correctives such as sucrose, Mel, syrup, aspartame, steviosin, sucralose, saccharin sodium, glycyrrhizin, xylitol, protein sugar, maltose alcohol, fructose, protein sugar, glucose, mannitol, sorbitol, citric acid, mucilage, ESS (as apple essence, Fructus Citri Limoniae essence, Fructus Citri tangerinae essence, flavoring pineapple essence, strawberry essence, Oleum Caryophylli, vanillin etc.) etc.; Coloring agent such as carmine, amaranth, lemon yellow, indigo, sunset yellow, chlorophyll etc.; Correctives, coloring agent can be selected one or more any mixture wherein respectively for use.
Described preparation method of preventing and treating the Chinese medicine composition of viral influenza and laryngopharyngeal diseases includes but are not limited to:
One, the preparation method of composition of leaf of Turpinia pomifera (Roxb) D O., freshener includes but are not limited to:
1, the drug particles or the powder that directly obtain of leaf of Turpinia pomifera (Roxb) D O. via disintegrating process.
2, leaf of Turpinia pomifera (Roxb) D O. adds water 5-10 and doubly measures, decoct 2 times, each 1.5 hours, filter, merging filtrate, filtrate concentrates, drying, Turpinia pomifera(Roxb) D O. extract.
3, leaf of Turpinia pomifera (Roxb) D O. water boiling and extraction filters, and merging filtrate is concentrated into relative density 1.1 (80 ℃ of heat are surveyed), puts coldly, adds ethanol and makes that to contain the alcohol amount be 40%～80%, leaves standstill and makes precipitation, gets supernatant, reclaims ethanol, concentrate, drying, Turpinia pomifera(Roxb) D O. extract.
4, leaf of Turpinia pomifera (Roxb) D O., or pulverize, with aquiferous ethanol immersion, percolation, collect percolate and reclaim ethanol, filter, concentrate, drying gets Turpinia pomifera(Roxb) D O. extract.The percolation concentration of alcohol for more excellent be 20%～75% ethanol, preferable percolation ethanol is Diluted Alcohol.
5, leaf of Turpinia pomifera (Roxb) D O., or pulverize, to measure aquiferous ethanol with 5～10 times and soak, reflux, extract, 2 times filters, and merging filtrate reclaims ethanol, concentrates, and drying gets Turpinia pomifera(Roxb) D O. extract.Preferable extraction ethanol is preferably Diluted Alcohol.
6, the bright product squeezing of leaf of Turpinia pomifera (Roxb) D O. extracting juice is refining, or adds mixed with excipients, gets Turpinia pomifera(Roxb) D O. extract.
7, the leaf of Turpinia pomifera (Roxb) D O. extract drugs concentrated solution that obtains of method 2～6 is mixed thoroughly with styrene type macroporous resin, adds the styrene type macroporous resin post, water elution is removed impurity, and 20%～85% ethanol elution is also collected the merging eluent, concentrates, drying gets Turpinia pomifera(Roxb) D O. extract.Preferable eluting concentration of alcohol is 60%.
8, the leaf of Turpinia pomifera (Roxb) D O. extract drugs concentrated solution that obtains of method 2～6, the immiscible middle polarity organic solvent extraction of water reclaims organic solvent, Turpinia pomifera(Roxb) D O. extract, organic solvent can be selected n-butyl alcohol, ethyl acetate, ether etc. for use, is preferably ethyl acetate.
9, leaf of Turpinia pomifera (Roxb) D O. is pulverized, and with supercritical extraction device extraction separation, gets Turpinia pomifera(Roxb) D O. extract.
10, Turpinia pomifera(Roxb) D O. extract or extracting solution add the excipient premixing, drying, the Turpinia pomifera(Roxb) D O. extract preparation intermediate that obtains.Described excipient such as starch, dextrin, micropowder silica gel, cyclodextrin, Polyethylene Glycol, lactose etc.
11, various pharmaceutical preparatioies or the health food service form made of leaf of Turpinia pomifera (Roxb) D O. powder or Turpinia pomifera(Roxb) D O. extract and freshener, correctives, aromatic, coloring agent and medically acceptable carrier or excipient.
Two, contain have relieving sore-throat by clearing away heat, one or more the Turpinia pomifera(Roxb) D O. extract of combination in any of the Chinese medicine of antipyretic and antidote functions and extract thereof, include but are not limited to:
1, leaf of Turpinia pomifera (Roxb) D O. or extract and have the Chinese medicine extract of relieving sore-throat by clearing away heat, antipyretic and antidote functions and various pharmaceutical preparatioies or health food service form that freshener, correctives, aromatic, coloring agent and medically acceptable carrier or excipient are made.
2, leaf of Turpinia pomifera (Roxb) D O. and have the Chinese medicine water extraction of relieving sore-throat by clearing away heat, antipyretic and antidote functions, refining or aqueous alcohol, organic solvent extraction, refining, obtain the Turpinia pomifera(Roxb) D O. mixed extract, described extracting method is a kind of in extraction respectively, united extraction or the part united extraction; The Turpinia pomifera(Roxb) D O. mixed extract that obtains or various pharmaceutical preparatioies or the health food service form made with the mixture of Chinese medicine extract and freshener and correctives, coloring agent and medically acceptable carrier or excipient with relieving sore-throat by clearing away heat, antipyretic and antidote functions.
Described a kind of preparation method of preventing and treating the Chinese medicine composition of viral influenza and laryngopharyngeal diseases, being preferably with Diluted Alcohol is to extract solvent, reflux or the percolation extraction, merge extractive liquid,, decompression recycling ethanol, concentrating under reduced pressure, spray drying (or adds mixed with excipients, spray drying), collect various pharmaceutical preparatioies or health food service form that dried powder and freshener and medically acceptable carrier or excipient are made, as be made for tablet, spray, aerosol, capsule, granule, mixture, medicinal tea, syrup etc.; Be preferably the oral cavity and contain formulation, as buccal tablet, larynx moistening candy, chewable tablet etc.
Described a kind of method of quality control of preventing and treating the Chinese medicine composition of viral influenza and laryngopharyngeal diseases includes but are not limited to:
1, leaf of Turpinia pomifera (Roxb) D O. is differentiated:
A, get this product an amount of (being equivalent to Turpinia pomifera(Roxb) D O. medical material 2g), or porphyrize, add water 30ml, heating makes dissolving, puts coldly, filters, filtrate is put on the polyamide column (80～100 order 1g, dry column-packing), adds water 150ml, eluting, discard water liquid, reuse ethanol 30ml eluting, eluent evaporate to dryness, add methanol 1ml and make dissolving, as need testing solution.Other gets leaf of Turpinia pomifera (Roxb) D O. control medicinal material 1g, adds water 50ml, little boiling 15 minutes, with method by polyamide column and make control medicinal material solution.Test according to thin layer chromatography (2005 editions one appendix VI B of Chinese Pharmacopoeia), draw each 5 μ l of above-mentioned two kinds of solution, put respectively on the silica gel g thin-layer plate of same usefulness 0.5% sodium hydroxide solution preparation, with ethyl acetate-butanone-formic acid-water (6: 3: 1: 1) be developing solvent, launch, take out, dry, spray is put under the ultra-violet lamp (365nm) and is inspected with the aluminum chloride test solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.
B, get this product an amount of (being equivalent to Turpinia pomifera(Roxb) D O. medical material 8g), or porphyrize, it is an amount of to add water, and heating makes dissolving, regulates pH value to 1～2 with hydrochloric acid, be transferred in the separatory funnel, extract 4 times (centrifugal in case of necessity) with the ethyl acetate medicine that shakes, the combined ethyl acetate extracting solution reclaims ethyl acetate to doing, residue adds ethanol 1ml makes dissolving, as need testing solution.Other gets the ursolic acid reference substance, adds ethanol and makes the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography (2005 editions one appendix VI B of Chinese Pharmacopoeia), draw each 2 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, (20: 5: 8: 0.5) be developing solvent, expansion was taken out with cyclohexane extraction-chloroform-ethyl acetate-glacial acetic acid, dry, spray is with 10% ethanol solution of sulfuric acid, and 100 ℃ to be heated to the speckle colour developing clear, puts respectively under daylight and the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle or the fluorescence speckle of same color respectively.
2, freshener is differentiated:
A, Mentholum and (or) Borneolum Syntheticum differentiates: get this product an amount of (be equivalent to menthol or (with) Borneolum Syntheticum about 2～3mg), put in the 250ml round-bottomed flask, add water 50ml, connect volatile oil determination apparatus, till the determinator upper end adds water and makes when being full of scale part and overflow and going into flask, add ethyl acetate 1ml again, connect reflux condensing tube, be heated to and boil, and keep little and boiled 30 minutes, liquid in the volatile oil determination apparatus is moved in the separatory funnel, divide and get acetic acid ethyl fluid as need testing solution.Other get Mentholum and (or) the Borneolum Syntheticum reference substance, add ethyl acetate and make the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography (2005 editions one appendix VI B of Chinese Pharmacopoeia), draw each 5 Ma of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with cyclohexane extraction-ethyl acetate (17: 3) is developing solvent, launch, take out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear that hot blast blows to the speckle colour developing.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
B, Oleum Eucalypti are differentiated: get this product an amount of (being equivalent to Oleum Eucalypti 0.2ml), put in the 250ml round-bottomed flask, add water 50ml, connect volatile oil determination apparatus, till the determinator upper end adds water and makes when being full of scale part and overflow and going into flask, add ethyl acetate 1ml again, connect reflux condensing tube, be heated to and boil, and keep little and boiled 30 minutes, liquid in the volatile oil determination apparatus is moved in the separatory funnel, divide and get acetic acid ethyl fluid as need testing solution.Other gets the eucalyptol reference substance, adds ethyl acetate 1ml and makes dissolving, makes reference substance solution.According to thin layer chromatography (2005 editions one appendix VI B of Chinese Pharmacopoeia) test, draw each 2 Ma of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with cyclohexane extraction-ethyl acetate (9.5: 0.5) is developing solvent, launches, and takes out, dry, spray is with 1% vanillin sulfuric acid solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
3, ursolic acid content is measured:
According to high effective liquid chromatography for measuring (2005 editions one appendix VI D of Chinese Pharmacopoeia).
Chromatographic condition with system suitability test be filler with the octadecylsilane chemically bonded silica; 20～7) or acetonitrile-water (70～80: 30～20) be mobile phase with methanol-water (80～93:; Detect wavelength 207～220nm, preferred 210nm.
Number of theoretical plate calculates by the ursolic acid peak should be not less than 1500.
It is an amount of that the preparation precision of reference substance solution takes by weighing the ursolic acid reference substance, adds dehydrated alcohol and make the solution that every 1ml contains 60 μ g, promptly.
It is an amount of that this product is got in the preparation of confession need testing solution, or porphyrize, get that an amount of (be equivalent to leaf of Turpinia pomifera (Roxb) D O. 8～16g), accurately claim (amount) calmly, it is an amount of to add water, heating or supersound process (power 300W, frequency 25kHz) made dissolving in 30 minutes, regulate pH value to 1～2, be transferred in the separatory funnel with hydrochloric acid, extract 4 times (centrifugal in case of necessity) with the ethyl acetate medicine that shakes, the combined ethyl acetate extracting solution reclaims ethyl acetate to doing the residue anhydrous alcohol solution, be transferred in the 10ml measuring bottle, add dehydrated alcohol to scale, shake up, filter, get subsequent filtrate, promptly.
Accurate respectively reference substance solution and each the 10 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly.
4, Mentholum assay
Measure according to gas chromatography (2005 editions one appendix VI E of Chinese Pharmacopoeia).
Chromatographic condition and system suitability test polymerization-cross-linked polyethylene glycol-20M capillary column (column length 30m, internal diameter 0.32mm, film thickness 0.25 μ m); Column temperature is temperature programming, and initial temperature is 100 ℃, with raise 5 ℃ speed to 150 ℃ of per minute, and per minute 30 ℃ the speed to 200 ℃ that raises again; Split sampling, split ratio are 3: 1.Number of theoretical plate calculates by the Mentholum peak should be not less than 50000.
It is an amount of that correction factor mensuration is got n-octadecane, and accurate the title decides, and adds cyclohexane extraction and makes the solution that every 1ml contains 1mg, as inner mark solution.It is an amount of that other gets the Mentholum reference substance, and accurate the title decides, and adds cyclohexane extraction and makes the solution that every 1ml contains 0.2mg, in contrast product solution.Accurate reference substance solution 5ml and the inner mark solution 1ml of drawing puts in the 10ml measuring bottle, adds cyclohexane extraction to scale, shakes up, and draws 2 μ l, inject gas chromatograph, the calculation correction factor.
The algoscopy precision takes by weighing this product (being equivalent to Mentholum 15 μ g), or porphyrize, adds water 100ml, press determination of volatile oil method (2005 editions one appendix X D of Chinese Pharmacopoeia) and measure, add cyclohexane extraction 2ml in the volatile oil extractor side pipe, extracted 2 hours, after treating the clarification of cyclohexane extraction layer, the cyclohexane extraction layer is transferred in the same 10ml measuring bottle the accurate inner mark solution 1ml that adds with the about 3ml of cyclohexane extraction, add cyclohexane extraction again to scale, shake up, draw 2 μ l, inject gas chromatograph, measure, promptly.
The specific embodiment
Embodiment 1: buccal tablet
Leaf of Turpinia pomifera (Roxb) D O. 2500g Oleum menthae 2ml Mentholum 0.6g
Borneolum Syntheticum 1.0g Fructus Citri Limoniae oil 0.6ml citric acid 0.8g
Betacyclodextrin 160g mannitol 150g starch 80g
Aspartame 6g magnesium stearate 0.8g
Preparation method:
Get leaf of Turpinia pomifera (Roxb) D O., pulverize, add the Diluted Alcohol soaked overnight, percolation is collected the about 20L of percolate, merges, and decompression recycling ethanol concentrates, and adds betacyclodextrin 120g, mixing, and 65 ℃～85 ℃ insulations, spray drying is collected spray-dried powders, and is standby; Other gets betacyclodextrin 40g, adds about 2 times of water gaging mixings, adds Oleum menthae, Mentholum, Borneolum Syntheticum, fully grind, add starch, mixing, cold drying is pulverized, with above-mentioned spray-dried powders, mannitol, citric acid mixing, add cochineal solution and make granule in right amount, cold drying sprays into the alcoholic solution of Fructus Citri Limoniae oil, mixing adds magnesium stearate, aspartame, mixing, be pressed into 1000, or coating, promptly.
Buccal tablet with present embodiment is tested
1, bacteriostatic test: extracorporeal bacteria inhibitor test shows that buccal tablet of the present invention all has in various degree inhibitory action to staphylococcus aureus, streptococcus pneumoniae, Salmonella typhimurium, escherichia coli, staphylococcus epidermidis, pseudomonas aeruginosa, streptococcus salivarius, micrococcus scarlatinae, staphylococcus haemolyticus etc.
2, analgesic activity: carrying out anti-inflammation detumescence test with Kunming mouse, is blank with the normal saline, and the result shows that buccal tablet of the present invention can obviously suppress Oleum Tiglii and cause mice ear and reduce mouse writhing number of times due to the acetic acid.
3, treatment viral influenza clinical effectiveness
Through making a definite diagnosis viral influenza 76 examples, wherein male 31 examples, women 45 examples, age 12-61 year.
Instructions of taking: buccal, one time 1, every 2 hours 1 time, one day 6 times.
Efficacy evaluation:
Recovery from illness: in the medication 3 days, temperature recovery is normal, aches all over, headache, dry pharynx, laryngopharynx swelling and pain obviously alleviate, and disappears with interior above-mentioned symptom and sign in 5 days;
Produce effects: in the medication 5 days, temperature recovery is normal, ache all over, headache, dry pharynx, laryngopharynx swelling and pain alleviate, or above-mentioned symptom and sign has a disappearance;
Effectively: in the medication 5 days, generate heat, ache all over, headache, dry pharynx, laryngopharynx swelling and pain alleviate;
Invalid: as not reach effective standard.
The curative effect statistics:
The clinical effectiveness statistical table of table 1 treatment viral influenza
| The example number | Recovery from illness | Produce effects | Effectively | Invalid | Cure rate (%) | Total effective rate (%) |
| 76 | 65 | 7 | 4 | 0 | 85.5 | 100 |
4, treatment laryngopharyngeal diseases clinical effectiveness
Through making a definite diagnosis laryngopharyngeal diseases 55 examples, wherein male 23 examples, women 32 examples in age 13-62 year, are divided into 2 groups, test group (first group) 35 examples, matched group (second group) 20 examples at random.
Instructions of taking:
The first group: buccal tablet, buccal, one time 1, every 2 hours 1 time, one day 6 times.
The second group: Turpinia pomifera(Roxb) D O. granule (Shanxiang Pharmaceutical Co., Ltd., Jiangxi), by specification is taken.
Efficacy evaluation:
Recovery from illness: in the medication 5 days, red swelling of the pharynx pain, swallow foreign body sensation, dry pharynx, sound is bad-looking, body is tired, heating obviously alleviates, disappeared with interior above-mentioned symptom and sign in 7 days;
Produce effects: in the medication 7 days, red swelling of the pharynx pain, swallow foreign body sensation, dry pharynx, sound is bad-looking, body is tired, heating obviously alleviates, or above-mentioned symptom and sign have more than one and disappear;
Effectively: in the medication 7 days, red swelling of the pharynx pain, swallow foreign body sensation, dry pharynx, sound is bad-looking, body is tired, heating is than improving before the medication;
Invalid: as in the medication 7 days, not reach effective standard or deterioration person on the contrary.
The curative effect statistics:
The clinical effectiveness statistical table of table 2 treatment laryngopharyngeal diseases
| The example number | Recovery from illness | Produce effects | Effectively | Invalid | Cure rate (%) | Total effective rate (%) | |
| First group second group | 35 20 | 26 13 | 5 4 | 4 3 | 0 0 | 74.2 65.0 | 100 100 |
In sum, preparation of the present invention to preventing and treating viral influenza and the laryngopharyngeal diseases effect is remarkable, is better than the Turpinia pomifera(Roxb) D O. granule, and has reduced the taking dose of always taking leaf of Turpinia pomifera (Roxb) D O. than Turpinia pomifera(Roxb) D O. granule.
Embodiment 2: throat lozenge
Leaf of Turpinia pomifera (Roxb) D O. 2000g Oleum menthae 2ml Mentholum 0.6g
Borneolum Syntheticum 1g Oleum Eucalypti 0.6ml citric acid 0.8g
Betacyclodextrin 160g sorbitol 220g starch 100g
Steviosin 3g magnesium stearate 1.5g
Preparation method:
Get leaf of Turpinia pomifera (Roxb) D O., add the Diluted Alcohol reflux, extract, 2 times, each 1.5 hours, merge extractive liquid, was put coldly, filters, and decompression filtrate recycling ethanol concentrates, and adds betacyclodextrin 120g, starch, mixing, and vacuum drying is pulverized, and is standby; Other gets betacyclodextrin 40g, adds about 2 times of water gaging mixings, and adding Oleum menthae, Mentholum, Borneolum Syntheticum, Oleum Eucalypti fully grind, add an amount of sorbitol, mixing, cold drying, pulverize, with above-mentioned drying and crushing powder, steviosin, surplus sorbitol, citric acid, an amount of indigo solution mixing, the system granule, cold drying, mixing adds magnesium stearate, mixing, be pressed into 1000, or coating, promptly.
Embodiment 3: granule
Leaf of Turpinia pomifera (Roxb) D O. 2000g Flos Lonicerae 300g Oleum menthae 1ml
Mentholum 0.2g Borneolum Syntheticum 0.5g Oleum Eucalypti 0.3ml
Betacyclodextrin 250g
Preparation method:
Get leaf of Turpinia pomifera (Roxb) D O., Flos Lonicerae, pulverize, add Diluted Alcohol and soak reflux, extract, 3 times, each 1 hour, filter, merge extractive liquid,, decompression recycling ethanol adds betacyclodextrin 230g, and mixing is concentrated into an amount of thick paste, and is standby; Other gets betacyclodextrin 20g, adds about 2 times of water gaging mixings, and adding Oleum menthae, Mentholum, Borneolum Syntheticum, Oleum Eucalypti fully grind, and the adding dextrin is an amount of, mixing, cold drying is pulverized, with above-mentioned concentrated thick paste, an amount of dextrin and cane sugar powder mixing, make granule, drying is made 1000g; Or with above-mentioned concentrated thick paste, an amount of dextrin and steviosin 3.3g, mixing is made granule, drying is made 650g, promptly.
Embodiment 4: mixture
Leaf of Turpinia pomifera (Roxb) D O. 1200g Radix Scutellariae 250g Herba Houttuyniae 160g
Oleum menthae 1ml Mentholum 0.3g
Preparation method:
Get leaf of Turpinia pomifera (Roxb) D O., Radix Scutellariae, Herba Houttuyniae, decoct with water 2 times, each 1 hour, collecting decoction filters, and filtrate decompression is concentrated into the clear paste that relative density is 1.10～1.12 (80 ℃), put coldly, add ethanol and make and contain alcohol amount and reach 75%, stir evenly, left standstill 24 hours, filter, filtrate recycling ethanol also is concentrated into the clear paste of relative density 1.18～1.22 (80 ℃), adds water to about 1000ml, cold preservation filters; Other gets Oleum menthae, Mentholum adds in the 2ml polyoxyethylene sorbitan monoleate, adds a small amount of medicinal liquid again, and mixing adds medicinal liquid, steviosin 0.4g, EDTA-2Na0.5g then, and mixing filters, and adds water to 1000ml, mixing, and packing, sterilization, promptly.
Embodiment 5: spray
Leaf of Turpinia pomifera (Roxb) D O. 1200g 100g Radix Ophiopogonis Flos Lonicerae 100g
Oleum menthae 0.3ml Borneolum Syntheticum 1.2g
Preparation method:
The above five tastes, leaf of Turpinia pomifera (Roxb) D O., Radix Ophiopogonis, Flos Lonicerae decoct with water 3 times, each 1 hour, collecting decoction filters, and filtrate decompression is concentrated into the clear paste that relative density is 1.10～1.15 (80 ℃), put cold, add ethanol and make and contain alcohol amount and reach 75%, stir evenly, left standstill 24 hours, filter, filtrate recycling ethanol also is concentrated into the clear paste of relative density 1.18～1.22 (80 ℃); Oleum menthae, Borneolum Syntheticum and an amount of dissolve with ethanol add in the 5ml polyoxyethylene sorbitan monoleate, slowly join in the above-mentioned medicinal liquid mixing.Steviosin 1g, EDTA-2Na0.5g add hot water and dissolve in right amount, add in the above-mentioned medicinal liquid, filter, and add water to 1000ml, and mixing filters, fill, promptly.
Embodiment 6:
Leaf of Turpinia pomifera (Roxb) D O. 1500g Herba Houttuyniae 500g Oleum menthae 1ml
Preparation method 1 (mixture): above three flavors, except that Oleum menthae, Herba Houttuyniae adds the water distillation, collect the about 500ml of distillate, it is standby to collect distillate, and medicinal residues and leaf of Turpinia pomifera (Roxb) D O. decoct with water 2 times, each 1.5 hours, collecting decoction filters, and filtrate and above-mentioned distillate merge, being evaporated to relative density is the clear paste of 1.10～1.12 (80 ℃), put coldly, add ethanol and make and contain alcohol amount and reach 75%, stir evenly, left standstill 24 hours, filter, filtrate recycling ethanol also is concentrated into the clear paste of relative density 1.18～1.22 (80 ℃), and is standby; Other gets Oleum menthae, steviosin 0.4g, EDTA-2Na0.5g add in the above-mentioned distillate, and mixing with above-mentioned clear paste mixing, adds water to 1000ml, and mixing filters, packing, promptly.
Preparation method 2 (buccal tablet): above three flavors, except that Oleum menthae, leaf of Turpinia pomifera (Roxb) D O., Herba Houttuyniae add Diluted Alcohol and soak, reflux, extract, 3 times each 1 hour, filters, merge extractive liquid,, decompression recycling ethanol adds betacyclodextrin 160g, mixing, spray drying, collect spray-dried powders, with cane sugar powder 300g, sorbitol 100g, starch 80g, citric acid 1g mixing, the system granule, dry, spray into the alcoholic solution of Oleum menthae, an amount of Fructus Citri tangerinae essence, mixing adds magnesium stearate 1.2g, mixing, be pressed into 1000, or coating, promptly.
Embodiment 7: the method for quality control of embodiment 1 buccal tablet
3 of this product are got in [discriminating] (1), porphyrize is put in the 250ml round-bottomed flask, adds water 50ml, connect volatile oil determination apparatus, till determinator upper end adds water and makes when being full of scale part and overflow and going into flask, add ethyl acetate 1ml again, connect reflux condensing tube, be heated to and boil, and keep little and boiled 30 minutes, the liquid in the volatile oil determination apparatus is moved in the separatory funnel, divide and get acetic acid ethyl fluid as need testing solution.Other gets Mentholum, Borneolum Syntheticum reference substance, adds ethyl acetate and makes the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography (2005 editions one appendix VI B of Chinese Pharmacopoeia), draw each 5 Ma of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with cyclohexane extraction-ethyl acetate (17: 3) is developing solvent, launch, take out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear that hot blast blows to the speckle colour developing.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(2) get 1 of this product, porphyrize adds water 30ml, and little boiling 5 minutes put cold, filter, filtrate is put on the polyamide column (80～100 order 1g, dry column-packing), adds water 150ml, eluting, discard water liquid, reuse ethanol 30ml eluting, the eluent evaporate to dryness adds methanol 1ml and makes dissolving, as need testing solution.Other gets leaf of Turpinia pomifera (Roxb) D O. control medicinal material 1g, adds water 50ml, little boiling 15 minutes, with method by polyamide column and make control medicinal material solution.Test according to thin layer chromatography (2005 editions one appendix VI B of Chinese Pharmacopoeia), draw each 5 μ l of above-mentioned two kinds of solution, put respectively on the silica gel g thin-layer plate of same usefulness 0.5% sodium hydroxide solution preparation, with ethyl acetate-butanone-formic acid-water (6: 3: 1: 1) be developing solvent, launch, take out, dry, spray is put under the ultra-violet lamp (365nm) and is inspected with the aluminum chloride test solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.
[assay] is according to high effective liquid chromatography for measuring (2005 editions one appendix VI D of Chinese Pharmacopoeia).
Chromatographic condition with system suitability test be filler with the octadecylsilane chemically bonded silica; With methanol-water (88: 12) is mobile phase; Detect wavelength 210nm.Number of theoretical plate calculates by the ursolic acid peak should be not less than 4000.
It is an amount of that the preparation precision of reference substance solution takes by weighing the ursolic acid reference substance, adds dehydrated alcohol and make the solution that every 1ml contains 60 μ g, promptly.
10 of this product are got in the preparation of need testing solution, and accurate the title decides, and porphyrize is got about 5g, add the about 25ml of water, supersound process (power 300W, frequency 25kHz) 30 minutes is regulated pH value to 1～2 with hydrochloric acid, be transferred in the separatory funnel, extract 4 times (centrifugal in case of necessity), each 30ml with the ethyl acetate medicine that shakes, the combined ethyl acetate extracting solution reclaims ethyl acetate to doing the residue anhydrous alcohol solution, be transferred in the 10ml measuring bottle, add dehydrated alcohol, shake up to scale, filter, get subsequent filtrate, promptly.
Accurate respectively reference substance solution and each the 10 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly.
Every of this product contains leaf of Turpinia pomifera (Roxb) D O. with ursolic acid (C
30H
48O
3) meter, must not be less than 0.12mg.
Claims (4)
1. Chinese medicine composition of preventing and treating viral influenza and laryngopharyngeal diseases is characterized in that this Chinese medicine composition is made up of leaf of Turpinia pomifera (Roxb) D O. and freshener, and freshener is one or more combination in any in Oleum menthae, Mentholum, Borneolum Syntheticum, the Oleum Eucalypti; Leaf of Turpinia pomifera (Roxb) D O. and freshener weight proportion are:
Leaf of Turpinia pomifera (Roxb) D O.: 1000～5000 weight portion fresheners: 0.1～30 weight portion.
2. the Chinese medicine composition of preventing and treating viral influenza and laryngopharyngeal diseases according to claim 1; it is characterized in that to contain in this Chinese medicine composition and have relieving sore-throat by clearing away heat; one or more combination in any of the Chinese medicine of antipyretic and antidote functions and extract thereof, as: watermelon crystal; Herba Sarcandrae; Flos Lonicerae; Radix Scutellariae; Fructus Canarii; Fructus Momordicae; Semen Sterculiae Lychnophorae; FRUCTUS TERMINALIAE IMMATURUS; Radix Glycyrrhizae; Radix Isatidis; Folium Isatidis; the artificial Calculus Bovis; Margarita powder; Flos Farfarae; Radix Rehmanniae; Fructus Mume; Flos Chrysanthemi; Flos Chrysanthemi Indici; Flos Trollii; Radix Scrophulariae; Radix Platycodonis; Fructus Gardeniae; Radix Ophiopogonis; Fructus Forsythiae; Radix Sophorae Tonkinensis; Radix Wikstroemae; fresh Succus Bambusae; Chimonanthus Nitens; Herba Houttuyniae; Herba Polygalae Japonicae; the Fructus Chebulae; Ilex purpurea Hassk.[I.chinensis Sims; Herba Lophatheri; Folium Mori; Semen Armeniacae Amarum; Semen Oroxyli; Radix Tinosporae; Herba Menthae; in the Radix Picriae felterrae etc. one or more.
3. preparation method of preventing and treating the Chinese medicine composition of viral influenza and laryngopharyngeal diseases according to claim 1 is characterized in that comprising the following steps:
(1) leaf of Turpinia pomifera (Roxb) D O. water extraction, refining or aqueous alcohol, organic solvent extraction, refining obtain leaf of Turpinia pomifera (Roxb) D O. extract.
(2) various pharmaceutical preparatioies or the health food service form made of leaf of Turpinia pomifera (Roxb) D O. powder or Turpinia pomifera(Roxb) D O. extract and freshener and medically acceptable carrier or excipient.
4. preparation method of preventing and treating the Chinese medicine composition of viral influenza and laryngopharyngeal diseases according to claim 2 is characterized in that comprising the following steps:
(1) except that Chinese medicine extract with relieving sore-throat by clearing away heat, antipyretic and antidote functions and freshener, Turpinia pomifera(Roxb) D O. and the Chinese medicine water extraction with relieving sore-throat by clearing away heat, antipyretic and antidote functions, refining or aqueous alcohol, organic solvent extraction, refining obtain the Turpinia pomifera(Roxb) D O. mixed extract; Extracting method is any one in extraction respectively or united extraction or the part united extraction.
(2) Turpinia pomifera(Roxb) D O. mixed extract or Turpinia pomifera(Roxb) D O. extract and have the mixture of Chinese medicine extract of relieving sore-throat by clearing away heat, antipyretic and antidote functions and various pharmaceutical preparatioies or health food service form that freshener and medically acceptable carrier or excipient are made.
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